【文献分享】同时治疗皮肤和软组织以减少皱纹、恢复面部活力的新方法

In recent years, various noninvasive and minimally invasive procedures have been developed, mainly for skin tightening, primarily utilizing ultrasound, radiofrequency (RF), or laser energy. The RF modality has become widely adopted due to its ability to induce production of new collagen and elastin fibrils while enhancing the existing connective tissue structures, and cellular metabolism. Nonetheless, when it comes to facial appearance, counteracting only the signs of skin aging is part of the solution. The loss of density of underlying muscles plays an important role in overall facial appearance.

近年来，已经开发了各种非侵入性和微创手术，主要用于皮肤紧致，主要利用超声波、射频（RF）或激光能量。RF模式已被广泛采用，因为它能够诱导产生新的胶原蛋白和弹性蛋白原纤维，同时增强现有的结缔组织结构和细胞代谢。面部年轻化治疗中针对皮肤衰老的治疗是解决方案的一部分，底层肌肉密度的存留在整体面部外观中也起着重要作用。

To target both skin and facial muscle, monopolar RF and high-intensity facial muscle stimulation (HIFES) technology are combined in the novel device, which uniquely synchronizes both technologies to address the overall facial appearance. The mechanism of RF treatment is based on the oscillating electrical currents that flow through the skin tissue, where they are transformed into heat. The novel HIFES technology generates a strong electrical field that depolarizes the motor neurons innervating the facial elevators: frontalis muscle, zygomaticus major and minor, and risorius muscle.

为了同时针对皮肤和面部肌肉，有一种新设备同时结合了单极射频和高强度面部肌肉刺激（HIES）技术，以解决面部整体外观问题。射频治疗的机制是基于流经皮肤组织的振荡电流，产生热量。新的HIFES技术产生一个强电场，使支配面部提升肌（额肌、大颧肌和小颧肌以及斜肌）的运动神经元去极化。

This study aims to evaluate the safety and effectiveness of the novel device for facial wrinkles and rhytides treatment. We hypothesize that this novel treatment may facilitate the natural healing process following the thermal effects of RF and workload from HIFES, conceivably resulting inwrinkle reduction and skin tone improvement.

本研究旨在评估新型治疗装置的安全性和有效性。我们假设，这种新的治疗方法可能有助于RF的热效应和HIFES的工作量后的自然愈合过程，预期会有效减少皱纹和改善肤色。

*以原文为准

Study population

Twenty-four subjects (1 male and 23 females, for more details see Table 1) were enrolled at two study sites. At the time of enrollment, the inclusion and exclusion criteria and the subject medical history were reviewed. Inclusion criteria were subjects aged 21 years and older, understanding of the investigative nature of the treatment concerning potential benefits and side effects, presence of clearly visible wrinkles in the treatment area, willingness and ability to abstain from partaking in any facial treatments other than the study procedure during study participation, and willingness to comply with the study instruction to return to the clinic for the required visits and to have photographs of their face taken.

研究人群

选取在两个地点登记的24名受试者（1名男性和23名女性，更多细节见表1）。在入组时，对纳入和排除标准以及受试者病史进行了回顾。纳入标准：21岁及以上的受试者，了解治疗的潜在益处和不良反应，治疗区域是否存在明显的皱纹，在参与研究期间是否愿意和有能力不参与除本研究之外的任何面部治疗，以及愿意遵守研究指示，在诊所内进行必要的就诊并拍摄他们的面部照片。

Subjects who met any exclusion criteria, such as metal implants, local infection, or unhealed wounds in the treated area, were excluded from participation in the study.

符合任何排除标准的受试者，如金属植入物、局部感染或治疗区域未愈合的伤口，被排除在研究之外。

Treatment protocol

All patients received treatments with the novel EMFACE (BTL Industries, Inc., Boston, MA) device using RF and HIFES technology for the noninvasive reduction of wrinkles, rhytides, and overall improvement in facial contours. The treatment was performed on the forehead and both cheeks at the same time using adhesive singleuse applicators. Before each therapy, the treatment area was cleared of any cosmetics, lotions, jewelry, and prominent hairs. The treatment administration phase consisted of four 20-min treatment visits, delivered 5–10 days apart. At each therapy, the intensities of RF and HIFES stimulation (on a scale of 0%–100%, where RF was set to 100% by default) were adjusted according to the patient’s feedback concerning any possible discomfort.

治疗方案

所有患者都接受了新型EMFACE设备的治疗，该设备使用RF和HIFUS技术，无创减少皱纹、皱纹和全面改善面部轮廓。使用一次性粘合剂对前额和双颊同时进行治疗。每次治疗前，治疗区域都要清除任何化妆品、乳液、珠宝和突出的毛发。治疗管理阶段包括四次20分钟的治疗访问，间隔5-10天。在每次治疗中，根据患者关于任何可能的不适的反馈，调整RF和HIFES刺激的强度（在0%-100%的范围内，默认情况下RF设置为100%）。

All patients were required to complete all four treatments and three follow-up visits: immediately after the last treatment, at 1-month, and at 3-month follow-up (–10 days). Patients were monitored and examined for the occurrence of any adverse events throughout the study duration.

所有患者都需要完成所有四次治疗和三次随访：最后一次治疗后立即、1个月和3个月随访（-10天）。在整个研究期间，监测和检查患者是否发生任何不良事件。

*以原文为准

Out of the recruited 24 subjects (56.5 – 2.0 years, skin type I–IV), 17 completed the 3-month follow-up visit. All patients received wrinkle treatment with parameters set according to the patient’s feedback. During the treatment, the intensities ranged from 50–100% for HIFES and 80–100% for RF.

在招募的24名受试者（56.5-2.0岁，皮肤类型I-IV）中，17人完成了为期3个月的随访。所有患者都接受了根据患者反馈设置参数的皱纹治疗。在治疗过程中，HIFUS的强度范围为50-100%，RF的强度范围从80-100%。

FWES evaluation

The FWES evaluation resulted in a baseline value of 5.2 – 0.4 points (class II, median value = 5.0 points). At a 1-month follow-up visit, the FWES score decreased to 3.8 – 0.5 points (median value = 3.5, 1.4 points, p < 0.001; class II). The results peaked 3 months after the last treatment ( p < 0.001), averaging a score of 2.9 – 0.4 points (median value = 3.0 points, 2.3 points, class I).

FWES评估

FWES评估的基线值为5.2–0.4分（II级，中值=5.0分）。在一个月的随访中，FWES评分降至3.8-0.5分（中值=3.5，1.4分，p<0.001；II级）。结果在最后一次治疗后3个月达到峰值（p<0.001），平均得分为2.9-0.4分（中值=3.0分，2.3分，I级）。

3D analysis

Evaluating 3D photographs with QuantifiCare software, the patient’s baseline average wrinkle score was subaverage with 1.3 – 0.6 points. Gradually, it improved showing an average difference of +3.1 – 0.5 points ( p < 0.001) at 1-month follow-up, as shown in Figure 1. The improvement was maintained up to 3 months with an average score increase of +4.4 – 0.6 points ( p < 0.001). The skin evenness (3.5 – 0.4 points at baseline) of the whole face was enhanced on average by +3.7 – 0.5 points at a 1-month follow-up visit ( p < 0.001). At the 3-month follow-up, a significant improvement ( p < 0.001) by +5.1 – 0.6 points was achieved.

三维分析

使用QuantityCare软件评估3D照片时，患者的基线平均皱纹评分低于平均水平，为1.3-0.6分。如图1所示，在1个月的随访中，病情逐渐好转，平均差异为+3.1–0.5分（p<0.001）。这种改善持续了3个月，平均得分增加了+4.4–0.6分（p<0.001）。在1个月的随访中，整个面部的皮肤均匀度（基线时为3.5–0.4分）平均提高了+3.7–0.5分（p>0.001）。3个月的跟踪中，获得了+5.1–0.6分的显著改善（p<001）。

Subject satisfaction and therapy comfort

The majority of patients (87.5%, N= 21) agreed that the therapy was comfortable and 91.7% (N= 22) patients reported no or minimal discomfort during the treatment. There were no negative responses from the SSQ evaluation immediately after the treatment.At 1- and 3-month followups, satisfaction with results was high, achieving 95.5% and 95.0%, respectively. In addition, 87.5% of patients reported more lifted and tighter skin after the treatment during the whole study. The lifting effect is demonstrated in Figure 4. No adverse events or treatment-related side effects were observed.

受试者满意度和治疗舒适度

大多数患者（87.5%，N=21）同意治疗是舒适的，91.7%（N=22）的患者报告在治疗期间没有或只有轻微的不适。治疗后立即进行的SSQ评估没有负面反应。在1个月和3个月的随访中，对结果的满意度很高，分别达到95.5%和95.0%。此外，在整个研究过程中，87.5%的患者报告在治疗后皮肤更加隆起和紧致。提升效果如图4所示。未观察到不良事件或与治疗相关的副作用。

*以原文为准

The treatment by a novel EMFACE device simultaneously delivering RF and HIFES resulted in a significant improvement in overall facial appearance. Based on the outcomes from 3D analysis and FWES evaluation, the procedure leads to decreased facial wrinkle severity (36.6%) and improved skin quality (25.2%). The treatment proved its safety since no adverse events were documented.

新型EMFACE设备同时输送RF和HIFES进行治疗，显著改善整体面部外观。根据3D分析和FWES评估的结果，该手术降低了面部皱纹的严重程度（36.6%），改善了皮肤质量（25.2%）。由于没有记录不良事件，该治疗证明了其安全性。

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